Practice for the classification of capsules and tablets with lactase

Updated 18 February 2014

In future, capsules, tablets and similar products containing the enzyme lactase will, as a starting point, only be classified as medicinal products if they are presented as products that can prevent or treat diseases.

Lactase is an enzyme that helps to degrade lactose (milk sugar). Lactose is typically found in dairy products. Persons who do not produce sufficient quantities of the enzyme lactase to degrade the lactose (the milk sugar) ingested via food may benefit from swallowing a capsule/tablet with lactase at the beginning of a meal containing large quantities of lactose.

The presentation of lactase is a determining factor

So far, the Danish Medicines Agency has considered tablets, capsules and similar products containing lactase to be medicinal products based on the purpose of the products. However, the Danish Medicines Agency has assessed that products containing lactase are not medicinal products as a starting point, as such products are not comprised by the definition of medicinal products in section 2 of the Danish Medicines Act.

Products with lactase will still be regarded as medicinal products if they are presented as products for the prevention or treatment of disease.

If a product containing lactase for oral ingestion is not presented as a product for the prevention or treatment of disease, it can therefore be marketed as a dietary supplement from now on. Yet, this requires approval from the Danish Veterinary and Food Administration. For information about the marketing of products containing lactase as dietary supplements, please contact the Danish Veterinary and Food Administration

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